MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SYRINGE MODULE ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10014916
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ syringe module administration set wouldn't prime saline past the filter and caused the tubing to expand.The following information was provided by the initial reporter: "i have a bd syringe admin set, microbore tubing, with 0.2 micron low protein binding filter that wont prime with saline.Once the saline gets to the pressure disc, it just blows the disk p like a balloon and won't prime passed the disk.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary one used sample model 10014916, lot 22075068 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd filled with water and was unable to be flushed.The male luer and then filter was cut from the line.The set was able to be flushed once the filter was taken out of the line.Visual inspection under a microscope showed signs of excess solvent near the inlet of the filter.A quality notification was sent to the manufacturer.From the manufacturers investigation, the potential root cause for occlusion between the tubing and filter is related to an excess of solvent in the assembly and incorrect tubing handling method before to add solvent due to assembler error.A device history record review for model 10014916 lot number 22075068 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd alaris¿ syringe module administration set wouldn't prime saline past the filter and caused the tubing to expand.The following information was provided by the initial reporter: "i have a bd syringe admin set, microbore tubing, with 0.2 micron low protein binding filter that wont prime with saline.Once the saline gets to the pressure disc, it just blows the disk p like a balloon and won't prime passed the disk.".

• Brand Name: BD ALARIS¿ SYRINGE MODULE ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16541866
• Report Number: 9616066-2023-00447
• Device Sequence Number: 5923748
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/11/2025
• Device Catalogue Number: 10014916
• Device Lot Number: 22075068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown